Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial

Phase 4

Completed

• Conditions: Hypothermia
• Interventions: Drug: fentanyl and midazolam; Drug: remifentanil and propofol

• Registration Number: NCT00667043
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

The aim of this study is to increase knowledge about drug properties and effects during therapeutic hypothermia. The primary end point of this study is the time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Primary Completion: 2009-05
• Study Completion: 2010-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Treatment with therapeutic hypothermia following cardiac arrest (33-34°C) and analgesia/sedation required
• Patients must be 18 years or older
• Inclusion must be approved by the attending physician

Exclusion Criteria

• Pregnant women
• Cardiovascular unstable patients in a deteriorating circulatory status which require multiple other therapeutic measures that makes participation practically impossible
• Liver or renal failure defined as sequential organ failure assessment (SOFA)-score 3 or 4
• History of drug allergies, or contraindications for the study drugs
• Patients using a scheduled dose of any of the study drugs.
• Patients with a known substance abuse of opioids or benzodiazepines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group 1	fentanyl and midazolam	Midazolam and fentanyl; continuous intravenous infusions
Study group 2	remifentanil and propofol	Propofol and remifentanil; continuous intravenous infusion

Primary Outcome Measures

Name	Time	Method
time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.	2010

Trial Locations

Locations (2)

St. Olavs Hospital; 🇳🇴 Trondheim, Sør-Trøndelag, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Rogaland, Norway